SRDX - Surmodics downgraded at Needham on uncertainty over drug-coated balloon
- Surmodics, Inc. ( NASDAQ: SRDX ) lost sharply on Monday after Needham downgraded the medical device maker to Hold from Buy, citing uncertain prospects for the company’s investigational drug-coated balloon SurVeil.
- In January, Surmodics ( SRDX ) announced a reduction of 13% of staff in an attempt to cut costs after the FDA declined to approve SurVeil, citing the need for more data.
- “SurVeil is unlikely to receive FDA approval until late CY23 at the earliest in our view,” the analyst Mike Matson wrote, noting that the company would likely take several months to conduct additional animal testing for an amended filing.
- Assuming a potential amendment in the fall, Matson expects FDA to take several months to respond, meaning the earliest timeline for approval could be late 2023, and there is a risk it could be even 2024.
- The analyst also raised concerns about the sales momentum of the company’s commercialized products, Pounce and Sublime.
- Matson also noted additional uncertainty from Abbott’s ( ABT ) recent decision to acquire Cardiovascular Systems ( CSII ), which also has a drug-coated balloon in development.
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Surmodics downgraded at Needham on uncertainty over drug-coated balloon